Octet application "Assays under GxP Regulatory Environment"

By using tools compliant with GxP and simple operations, we enable productivity improvements in the analysis development and quality control of pharmaceuticals under regulatory environments.

As a regulatory requirement, biopharmaceuticals must be QC tested using methods that are robust and appropriately qualified and validated under GMP conditions. The Octet system for analyzing biomolecular interactions is a reliable system that facilitates method development for in-process testing and lot release testing, and it can be easily transferred to QC. Due to its ease of use and high throughput characteristics, it can achieve up to 40 times the productivity of ELISA and up to 16 times that of SPR equipment in specific GMP applications. ■ The Octet CFR software and FB server functionality maintain secure and traceable electronic records. ■ The IQ/OQ/PQ package guarantees the required conditions and operations. ■ Validation support services for software and biosensors are provided. *For more details, please refer to the PDF materials or feel free to contact us.

basic information

■ Fc receptor binding assay (Application Note 17) The safety and efficacy of antibody drugs can be significantly influenced not only by the antigen but also by the binding characteristics to FcγR. We rapidly measure the binding affinity of antibodies to FcγR, which is considered essential in the biopharmaceutical development process, across a wide range of affinities. ■ Ligand binding potency assay (Application Note 26) The ligand binding potency assay requires high reproducibility and precision in technology. Octet meets the stability required for lot release testing and is adopted as a method for evaluating the potency of drug candidates due to its user-friendliness and rapid measurement. ■ Potency measurement (Application Note 12) The measurement of potency and protein concentration is a critical process in the development of biopharmaceuticals. Common methods such as ELISA and HPLC are used, but Octet can be applied in both upstream and downstream processes, providing a more robust method for cell culture and media.